Vivo 40 Users Manual Issue A-1e

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7.3 Technical Alarm... 54 Cleaning the Vivo 40 and Replacement of Accessories ... 57

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8.1 Cleaning the Vivo 40 ... 57 8.2 Cleaning and Replacing the Patient Air Filters... 59 Maintenance ... 61

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9.1 Regular Maintenance Control ... 61 9.2 Service and Repair... 62 9.3 Storage... 62 9.4 Disposal ... 62 Technical Specifications ... 63

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10.1 Data ... 63 Accessories... 68

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11.1 Breas Accessories List... 68 Patient Settings... 69

2 Table of Contents BREAS Vivo 40 users manual

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1

Introduction WARNING!

Vivo 40 must only be used: •

For the intended treatment in accordance with this operating manual and with the instructions given by the responsible clinical personnel.

•

In accordance with the operating conditions specified in this operating manual.

•

In original and unmodified shape and only with accessories specified or approved by Breas Medical AB.

Every other use may lead to risk of personal injury! CAUTION!

Read this operating manual thoroughly so that you completely understand how the Vivo 40 is operated and maintained before taking it into use, to ensure correct usage, maximum performance and serviceability. WARNING!

Do not use the Vivo 40 for any kind of total ventilatory requirement. Breas Medical AB reserves the right to make changes to this product without any prior notification.

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Introduction 3 Vivo 40 users manual

1.1 What is the Vivo 40? The Vivo 40 is a pressure-supported and pressure-controlled ventilator. It has three modes of operation: PCV (Pressure Control Ventilation), PSV (Pressure Support Ventilation) and CPAP (Continuous Positive Airway Pressure). The PCV and PSV modes have an adjustable inspiratory trigger sensitivity setting which allows the patient to initiate ventilator-assisted breaths. • In the PCV mode (Pressure Control Ventilation), the ventilator provides assisted or controlled pressure-regulated breathing. In PCV mode, the clinician sets an inspiration time. The inspiratory pressure is set by the IPAP (Inspiratory Positive Airway Pressure) setting. The end-expiratory pressure is set by the EPAP (Expiratory Positive Airway Pressure) setting. • In the PSV mode (Pressure Support Ventilation), the ventilator’s expiratory trigger can also be adjusted allowing the ventilator to more easily match each patient’s needs. The inspiratory pressure is set by the IPAP setting. The end-expiratory pressure is set by the EPAP setting. • In the CPAP mode (Continuous Positive Airway Pressure), the ventilator provides a continuous positive airway pressure.

The Vivo 40 has a pressure sensor that continuously monitors output pressure to the patient and reference ambient pressure, so that the device automatically will compensate for altitude changes.

1.2 Intended Use The Vivo 40 is an assist ventilator intended to augment the breathing of spontaneously adult patients >66 lbs (>30 kg) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The Vivo 40 is not intended to provide the total ventilatory requirements of the patient. The Vivo 40 is intended to be used for both invasive and non-invasive applications. The Vivo 40 is intended to be operated by qualified and trained personnel. The Vivo 40 is intended for use in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. The Vivo 40 must always be prescribed by a licensed physician.

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The CPAP function is intended to deliver continuous positive airway pressure therapy for the treatment of obstructive sleep apnea, via non-invasive nasal or full-face masks.

1.3 Contraindications The use of the Vivo 40 is contraindicated on patients with severe respiratory failure without a spontaneous respiratory drive. The use of the Vivo 40 for positive pressure therapy may be contraindicated on patients: • Incapable of maintaining life- sustaining ventilation in the event of a brief circuit disconnection or loss of therapy. • Unable to maintain a patent airway or adequately clear secretions. • At risk for aspiration of gastric contents. • With a history of allergy or hypersensitivity to the mask materials where the risk from allergic reaction outweighs the benefit of ventilatory assistance.

Therapy with the Vivo 40 should not be prescribed when the following specific diseases or conditions are present: • Bullous lung disease • Pathologically low blood pressure • Severe cardiac arrhythmias • Coronary artery disease • Unstable angina pectoris • Decompensated cardiac failure or hypotension, particularly if associated with intravascular volume depletion • Recent thoracic surgery • Pneumothorax • Pneumomediastinum • Massive epistaxis or previous history of massive epistaxis (risk of recurrence) • Pneumoencephalus, recent trauma or surgery that may have produced cranio-nasopharyngeal fistula

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Introduction 5 Vivo 40 users manual

• Cerebral spinal fluid (CSF) leaks • Acute or unstable respiratory failure or insufficiency • Conditions predisposing to a risk of aspiration of gastric contents • Impaired ability to clear secretions

Caution should be used when prescribing positive airway pressure therapy for susceptible patients, such as patients with abnormalities of the cribriform plate, or prior history of head trauma. The use of CPAP therapy may be temporarily contraindicated if the patient exhibits signs of a sinus or middle ear infection.

1.4 About this Manual Always read this manual before setting up and using the Vivo 40 or performing maintenance on the machine, to ensure correct usage, maximum performance and serviceability. Breas Medical AB reserves the right to make changes to the contents of this manual without any prior notification. Audience

This manual is intended for patients and other lay users operating the Vivo 40. Care providers, clinical personnel, physicians and others who require a working knowledge of the Vivo 40 will find additional information on settings and functions in the Clinician’s Manual.

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Icons

In this manual, icons are used to highlight specific information. The meaning of each icon is explained in the table below. ICON

EXPLANATION

Warning! Risk of death and serious personal injury. Caution! Risk of minor or moderate injury. Risk of equipment damage, loss of data, extra work, or unexpected results. Note Information that may be valuable but is not of critical importance, tips. Reference Reference to other manuals with additional information on a specific topic.

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Safety Information

2.1 General User Precautions • The Vivo 40 must be switched off and on at least once a day. This is necessary in order for the Vivo 40 to perform a self test. • U.S. Federal law restricts this device for sale by or on order of a physician. • The Vivo 40 should not be used for any kind of total ventilatory requirement. • The Vivo 40 shall only be used by patients with spontaneous breathing. • Advice contained in this manual should not supersede instructions given by the prescribing physician. • If you are admitted to a hospital or are prescribed any other form of medical treatment, always inform the medical staff that you are on mechanical ventilation treatment. • Vivo 40 must only be used: – for the intended treatment in accordance with this operating manual and with the instructions given by the responsible clinical personnel; – in accordance with the operating conditions specified in this operating manual; – in original and unmodified shape and only with accessories specified or approved by Breas Medical AB.

• Do not use the Vivo 40 in the event of suspected damage to the device, unexplainable or sudden pressure, performance or sound changes during operation, or if the delivered air from the Vivo 40 is abnormally hot or emits an odor. Contact your responsible care provider for an inspection. • Inadequate use of device or accessories may cause loss of treatment or decreased performance. • The Vivo 40 therapy settings must always be based on medical supervision and must be changed by authorized clinical personnel only. Blood gas measurement should be performed when changing settings or changing to another device.

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• Always perform the procedure “Set up the Vivo 40 Before Use” on page 28 before using the Vivo 40. • Only use accessories recommended by Breas Medical AB. • Clinical personnel must read the Clinician’s manual thoroughly and understand the Vivo 40 operation before setting up and using the machine. • The user must read the user manual thoroughly and understand the Vivo 40 operation before using the machine. • All the physiological alarms of the Vivo 40 must be set at safe levels that will effectively warn the user of any risk. The alarm levels should be assessed considering the patient settings. Any change of settings or components may require the readjustment of the alarm levels. • Handle the Vivo 40 with care. • Make sure to place and pack the device in a way that prevents unintentional start of the machine. Due to the internal battery, the Vivo 40 may start if the Start/Stop button is pressed even without the AC power being connected. • Do not use the Vivo 40 while in a carry bag. Attach the rear lid and place the swivel in a down position when placing the Vivo 40 in the bag. • If using the Vivo 40 for a short intra hospital or vehicle transportation, the following cautions need to be observed: – Do not mount the Vivo 40 on a wheelchair or in a vehicle. – Make sure that the Vivo 40 stands securely in a upright position and cannot tilt or fall. – Do not use the Vivo 40 outdoors during rain or snowfall. – If the HA 01 humidifier is attached, make sure that it is not in use and that it is empty.

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Safety Information 9 Vivo 40 users manual

2.2 Electrical Safety • Do not operate the Vivo 40 if it has a damaged power cord or casing. • The Vivo 40 may not work properly if any part has been dropped, damaged or submerged in water. • To avoid electrical shock, disconnect the electrical supply to the Vivo 40 before cleaning. Do not immerse the Vivo 40 into any fluids. • The operator shall not touch accessible contacts of connectors and the patient simultaneously. • When handling the HA 01 humidifier, always turn off the Vivo 40 and disconnect the Vivo 40 from the AC power supply. • Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g. IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the valid version of the system standard IEC 60601-1-1. Therefore, everyone who connects additional equipment to the signal input part or signal output part configures a medical system is responsible that the system complies with the requirements of the valid version of the system standard IEC 60601-1-1. If in doubt, consult the technical service department or your local representative. • If an external battery is used, always disconnect it when the Vivo 40 is switched off. Otherwise there is a risk that the battery will discharge. • If the AC power source fails and the internal or the external battery activates, the HA 01 humidifier will be turned off automatically. It must be activated again manually, if humidification during battery use is necessary. • Only use the data connection to connect the Vivo 40 to the iCom or a PC.

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2.3 Environmental Conditions • Do not use the Vivo 40 in any toxic environment. • Do not use the Vivo 40 in environments where there are explosive gases or other flammable anesthetic agents present. • The air flow for breathing produced by the Vivo 40 can be as much as 10°F (5°C) higher than room temperature. Caution should be exercised if the room temperature is greater that 95°F (35°C). • If a room humidifier is used, place it at least 6 feet (2 meters) away from the Vivo 40. • The performance of the Vivo 40 may deteriorate at ambient temperatures below 41°F (5°C) and above 100°F (38°C). • Do not use the Vivo 40 while positioned in a warm place, such as direct sunlight. • The device complies with the EMC requirements of standards. Measures should include but not be limited to: – normal precautions with regard to relative humidity and conductive characteristics of clothing in order to minimize the build-up of electrostatic charges. – avoiding the use of radio emitting devices closer than 1 m to the Vivo 40. Examples include: radio emitting devices such as cellular or cordless telephones, microwave ovens and high-frequency surgery apparatus.

• The Vivo 40, all accessories and replacement parts must be disposed of in accordance with the local environmental regulations regarding the disposal of used equipment and waste. • The performance of the Vivo 40 and treatment of the patient may deteriorate if the operation conditions in “Technical Specifications” on page 63 are not fulfilled. Do not use the Vivo 40 immediately after storage or transport outside the recommended operating conditions.

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Safety Information 11 Vivo 40 users manual

2.4 Usage of Patient Circuit • Only use the Vivo 40 with a mask, patient tube and leakage port recommended by Breas Medical AB and your health care professional. • The Vivo 40 requires an intentional leak port instead of an actively controlled exhalation valve to remove exhaled gases from the patient circuit. Therefore, specific masks and patient circuits using an intentional leakage are required for normal operation. The pressurized air from the Vivo 40 causes a continuous flow of air to exhaust from the leak ports, flushing exhaled gas from the circuit. The Vivo 40 should be turned on and the intentional leak ports should be checked before application. • Do not breathe in the connected patient circuit unless the Vivo 40 is turned on and operating properly. • Do not use patient hoses or tubes made of static or electrically conductive material. • Patient connected parts and filter must be replaced regularly to ensure correct function of the Vivo 40. All replaced parts must be disposed of according to local environmental regulations regarding the disposal of used equipment and parts. • Periodically check for moisture in the patient circuit. When present, remove the moisture. Before attempting to dry the circuit, disconnect it from the Vivo 40 to ensure no water will flow back into the Vivo 40. • If the patient needs assistance to take off the patient interface, the patient shall not be left alone. This is to avoid the risk of re-breathing of CO2 in case of accidental ventilator failure. If the patient is using a full face mask (covering mouth and nose), the mask must be equipped with a safety entrainment valve.

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• Make sure that the ventilation holes in the mask or the leakage ports are never blocked or obstructed. These ports are used to prevent re-breathing of exhaled air. Re-breathing of exhaled gases for longer than several minutes can, in some circumstances, lead to suffocation. • At low CPAP pressures, the air flow through the ventilation holes in the mask or the leakage ports may be inadequate to clear all exhaled gases. Some re-breathing may occur. • Do not leave long lengths of air tubing around the top of the bed. It could twist around the patient’s head or neck while sleeping. • Always follow the instructions of the mask manufacturer.

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Safety Information 13 Vivo 40 users manual

2.5 Invasive Use • For invasive applications, assure that an intentional leakage port is present in the patient circuit. Install the leakage port as close as possible to the patient connection, to reduce the risk of rebreathing CO2. • When using the Vivo 40 invasively the low volume alarm and the low breath rate alarm must be carefully set, to ensure safe use. • The highest output from the HA 01 humidifier is 30 mgH2O/litre, which means that it does not fulfill the humidifier standard for invasive use. • The Vivo 40 is equipped with a low leakage alarm. The low leakage alarm is not a substitute for operator vigilance in ensuring that the leakage ports remains clear at all times. Periodically check the leakage ports during therapy. • In general as pressure decreases the potential of rebreathing increases. Lower pressures produce less flow through the leakage ports which may not clear all CO2 from the circuit to prevent rebreathing. • In general as inspiratory time increases the potential of CO2 rebreathing increases. A higher inspiratory time decreases the expiratory time allowing less CO2 to be cleared from the circuit before the next breath. I:E (inspiration time : expiration time) ratios close to 1:1 increase the potential of CO2 rebreathing. • Tracheal tubes, oral/nasal tubes etc with small inner diameters increase the resistance in the breathing circuit. • An external heated humidifier approved for invasive use or an appropriate HME (Heat and Moisture Exchanger, artificial nose)/HCH (Hygroscopic Condenser Humidifier) is recommended.

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2.6 Usage of Filters • Always use the Vivo 40 with patient air inlet filters installed. Only use filters that are specified in this manual. • Replace or clean the filters regularly to ensure correct function of the Vivo 40, especially when changing patient. Failure to replace or clean a dirty filter may cause the Vivo 40 to operate at higher temperatures than intended. • When operating the Vivo 40, make sure that the air inlet and filters are not obstructed or occluded. • The use of a high resistance bacteria filter on the output of the device may interfere with the operation of the patient disconnect function. It may also interfere with the device trigger function. • Do not connect any filter to the HA 01 humidifier.

2.7 Humidification • The HA 01 humidifier is intended for non-invasive use only. • Humidification must only be used if this has been prescribed by your physician. The Vivo 40 therapy settings must always be prescribed by a physician or other licensed health care professional, and be carried out by authorized clinical personnel. • Do not place the Vivo 40 with the HA 01 humidifier in a bag. • When the HA 01 humidifier is installed, the Vivo 40 must be located below the patient and on a flat surface. This is to prevent personal injury from accidental spillage or from excess water or condensation flowing down the patient tube and into the patient’s mask. Extra cautions should be taken for patients who are unable to guard their airways or cannot pull off the mask. • When using an external heated humidifier, it should be located below the Vivo 40 and the patient to prevent injury from accidental spillage. • If the condensation in the patient circuit is excessive, the use of a heated humidifier may require the installation of a water trap in the circuit. The water trap prevents any condensated water in the patient circuit from running into the patient airways and causing personal injury.

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Safety Information 15 Vivo 40 users manual

The use of an HME (Heat and Moisture Exchanger, artificial nose) or an external humidifier may require readjustment of the Vivo 40’s low-pressure alarm. • Certain HME’s and HCH’s (Hygroscopic Condenser Humidifiers) are sufficient to provide humidification when the Vivo 40 is used invasively. Check specific suppliers recommended use.

2.8 Cleaning and Maintenance • The Vivo 40 should be cleaned and maintained in accordance with this operating manual. • Do not attempt to autoclave or sterilize the Vivo 40. • Vivo 40 should be subjected to maintenance, service and control and any applicable upgrades, in accordance with Breas service instructions. • Vivo 40 shall only be repaired or modified in accordance with Breas service manuals, technical bulletins, and any special service instructions, by service technicians authorized by Breas Medical AB. • Do not under any circumstances attempt to service or repair the Vivo 40 yourself. If you do so, the manufacturer will no longer be responsible for the performance and safety of the Vivo 40. Furthermore, no warranty will be valid.

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2.9 Adverse Patient Symptoms If the patient experiences discomfort or any of the following symptoms while using the Vivo 40, a physician or responsible clinician shall be contacted immediately: • Bloated feeling from excessive swallowing of air while awake • Air continually leaking from the mouth while sleeping • Dryness of air passages or nose • Ear pain, runny nose or sinus discomfort • Day time sleepiness • Disorientation or memory lapse • Mood change or irritability • Skin sensitivity • Severe headache • Chest discomfort • Shortness of breath The following are potential side effects of non-invasive positive pressure therapy: • Ear discomfort • Conjunctivitis • Skin abrasions due to non-invasive interfaces • Aero phagia (gastric distension)

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2.10 Usage of Oxygen • The presence of oxygen can speed up combustion of inflammable materials. • If oxygen has been prescribed, connect the oxygen supply tube to the appropriate oxygen port of the nasal mask or breathing system connector. • At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on the pressure delivered, patient’s breathing pattern, mask selection, and leak rate. • When oxygen is used with the Vivo 40, the oxygen flow must be turned off when the Vivo 40 is not operating. • Ventilate the room adequately. • Do not smoke in a room where oxygen is being used. • Naked light bulbs and other sources of ignition must be kept a minimum of 6 feet (2 meters) away from the oxygen cylinder or any part of the patient circuit. • Do not use aerosols or solvents close to the oxygen supply, even when the oxygen supply is shut off. • When the Vivo 40 is not in operation, and the oxygen flow is left on, oxygen delivered into the patient tubing may accumulate within the machine enclosure. Oxygen accumulated in the machine enclosure will create a risk of fire. • Supplemental oxygen may trigger the low leakage alarm prematurely. • Supplemental oxygen flow may not exceed 15 liter/min. • Supplemental oxygen affects the accuracy of the volume and flow measurements. It is not recommended to use supplemental oxygen when target volume is active.

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Product Description

3.1 Main Components The Vivo 40 system contains the following components:

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1

6

5

7 8

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